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Temsirolimus

Published: July 26, 2026Updated: July 26, 2026

Temsirolimus is an antineoplastic medication used primarily to treat advanced renal cell carcinoma (kidney cancer) in patients with poor prognosis. As an mTOR inhibitor, it works by binding to intracellular proteins and blocking the mTOR pathway that controls cancer cell division, ultimately halting tumor growth.

Quick summary

Temsirolimus is an mTOR inhibitor chemotherapy agent used to treat advanced kidney cancer by stopping cancer cell division.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
L01EG01
RxNorm
657797
Generic
Temsirolimus
Class
atc-l01
Brands
Torisel
Availability
rx
Lactation
unknown
Routes
—
Forms
injection
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Dose studied in clinical trials above which significant toxicity was observed
Chronic overdose: Prolonged exposure above recommended weekly dose of 25mg IV
Immediate actions
Discontinue drug, supportive care, monitor vital signs and laboratory parameters
Antidote
No specific antidote available(Treatment is supportive and symptomatic)
Poison Control: 1-800-222-1222

Special Populations

9 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks to the fetus

Monitor

regular fetal monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

second third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks

Monitor

regular fetal monitoring and growth assessment

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

breastfeeding
unsafe
FDA Category
N
Dose Adjustment

avoid

Key Recommendations

breastfeeding should be discontinued during treatment and for at least 2 weeks after last dose

Monitor

monitor infant for adverse effects

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly
caution
FDA Category
N
Dose Adjustment

no specific adjustment

Key Recommendations

no dosage adjustment required but monitor for increased sensitivity to adverse effects

Monitor

regular monitoring of renal function and blood counts

Use with caution and monitor for adverse effects.

✗

pediatric_age

children adolescents
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

safety and efficacy not established in pediatric patients - use not recommended

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

mild moderate
caution
FDA Category
N
Dose Adjustment

no adjustment needed

Key Recommendations

no dosage adjustment required for mild to moderate renal impairment

Monitor

monitor renal function periodically

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

use with caution in severe renal impairment - monitor closely

Monitor

close monitoring of renal function

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild
caution
FDA Category
N
Dose Adjustment

no adjustment needed

Key Recommendations

no specific dose adjustment required but monitor closely

Monitor

monitor liver function tests and for adverse effects

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

moderate severe
unsafe
FDA Category
N
Dose Adjustment

avoid or reduce dose

Key Recommendations

use not recommended in severe hepatic impairment - if used, significant dose reduction may be required

Monitor

frequent liver function monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

drug_classWHO
2023

Drug class

Value:mTOR inhibitor

Mechanism-based classification

prescribingFDA
2023

FDA approval year

Value:2007

Regulatory approval information

usageFDA
2023

Primary indication

Value:Advanced renal cell carcinoma

Therapeutic indication

mechanismFDA
2023

Mechanism of action

Value:Inhibits mTOR kinase, blocking tumor cell proliferation

Pharmacodynamic properties

Primarily indicated for previously untreated patients with advanced renal cell carcinoma (kidney cancer) who have a poor prognosis. May be used in other cancers as determined by an oncologist.

Temsirolimus binds to an intracellular protein called FKBP-12, forming a complex that inhibits mTOR (mammalian target of rapamycin). This blocks signals that control cell division and proliferation, causing cancer cells to arrest in the G1 phase of the cell cycle, preventing tumor growth.

Administered intravenously by healthcare professionals. Common side effects include rash, fatigue, mouth sores, and metabolic changes. May cause immunosuppression and requires monitoring of blood counts and liver function. Contraindicated in pregnancy. Hypersensitivity reactions can occur; pre-medication with antihistamines is typically given.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy